Agency classClass IIOur severity:High FDA (Devices)·Z-1858-2016·Announced 2016-06-08

FDA Recalls Vistec X-Ray Detectable Sponges Due to Sterility Breach

The FDA is recalling Vistec X-Ray Detectable Sponges because a breach in the packaging barrier may have compromised their sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves compromised sterility of a medical device, which poses a risk of harm (infection) even though specific injury reports are not detailed in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm), Item Number 7319, manufactured by Covidien LLC. The recall is due to a breach of the packaging barrier, which may have compromised the sterility of the medical devices.

The affected units include all lots beginning with 100000010062 through lot 15J162962X. A total of 372,480 units were distributed nationwide in the United States, as well as in Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, and the United Kingdom.

Healthcare facilities and consumers should stop using these sponges immediately and contact the manufacturer or their supplier for instructions on how to return or dispose of the affected products.

The recalled product

Product: Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Sponges
Hazard: sterility-breach
infection-risk
Affected units: 372,480

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots beginning with 100000010062 through lot 15J162962X

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · sterility breach